Eli Lilly and Incyte have announced that the US Food and Drug Administration (FDA) has approved their COVID-19 therapy Olumiant (baricitinib) for the treatment of hospitalised adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.
This is the first and only FDA-approved Janus kinase (JAK) inhibitor for the treatment of hospitalised COVID-19 patients.
The approval follows placebo-controlled, double-blind, randomised trials and involves a recommended dose of 4mg once daily for 14 days or until final hospital discharge, whichever comes first.
“More than two years into the pandemic, COVID-19 is still hospitalising many people and burdening our healthcare system,” said Andre Kalil, Professor of Medicine at the University of Nebraska Medical Center.
“I’m encouraged by the FDA’s full approval of Olumiant for the treatment of these patients. While there are therapies currently available, there is still an urgent need for more options to help improve outcomes for patients hospitalised due to COVID-19.”
The FDA’s approval is also supported by results from phase 3 studies during which no new safety signals were identified.
“Nearly one million people with COVID-19 have been treated with Olumiant in approximately 15 countries worldwide,” said Patrik Jonsson, Eli Lilly’s senior vice president of Lilly Immunology and chief customer officer.
He added: “Today’s full approval reflects both our confidence in Olumiant’s role in treating these hospitalised patients and Lilly’s tireless efforts to support the medical community and patients in the ongoing fight against COVID-19.”
Baricitinib has been available in the US under emergency use authorisation (EUA) since November 2020. This will remain in place for hospitalised paediatric patients aged between two and 17 years who require various degrees of oxygen support.
The emergency authorisation is not an approval and is temporary for the duration where circumstances justify it.
Lilly has submitted applications for regulatory approval or authorisation to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow.